Validation Engineer

Overview

On Site
Full Time

Skills

Test Plans
Writing
Auditing
Documentation
IQ
OQ
PQ
Computerized System Validation
Regulatory Compliance
Good Manufacturing Practice
GAMP
Problem Solving
Conflict Resolution
Effective Communication
Collaboration
Document Management
Management
Database

Job Details

Responsibilities:
  • Designs and drafts validation sampling and testing plan/protocols.
  • Executes and reports on validation studies such as Process Validation, Cleaning Validation, CSV, Commissioning, IQ, OQ and PQ studies.
  • Resolve technical issues encountered during study execution.
  • Track and expedite the review and sign-off of qualification documentation.
  • Support execution of validation activities.
  • Interact with individuals from different departments to plan, execute, and complete qualification activities.
  • Drive the completion of validation efforts according to deadlines.
  • Write / guide the writing of departmental procedures required for validation.
  • Assist during internal and 3rd party audits wrt validation requirements.
  • Initiate CAPAs, NCRs and Change Requests where required and assist with investigations.
  • Assist with identifying maintenance and calibration requirements.
  • Coordinate suppliers wrt Validation activities including obtaining quotes from suppliers.
  • Validation administration such as updating the validation plan, maintaining databases, standard referencing of documentation.
  • Review Validation plans, protocols and SOPs written by other validation team members.
  • Manage workload arising from unscheduled events.
  • Other duties as assigned by management.

Requirements:
  • Validation Protocol Development and Execution: Expertise in creating and executing validation protocols (IQ, OQ, PQ, CSV, etc.).
  • Regulatory Compliance Knowledge: Strong understanding of FDA, cGMP, GAMP, and related regulatory standards.
  • Technical Problem-Solving: Ability to troubleshoot and resolve technical issues during validation.
  • Cross-Functional Collaboration: Effective communication and coordination with internal teams and external suppliers.
  • Documentation Management: Proficiency in managing validation documents, databases, and SOPs.
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